First Patient in Clinical Trial of i-cor® Device to Treat Cardiogenic Shock

Germany’s XENIOS® AG has announced that the first patient has been enrolled in the “SynCor” clinical trial of its CE-marked i-cor® Synchronized Cardiac Assist System for treating cardiogenic shock.

Background

XENIOS AG is the only company that can make the claim of having a single platform of minimally invasive products that do not require mechanical ventilation, sedation, and immobility, designed for physicians to treat the patient who either has certain singular lung or heart issues, or has concomitant lung and heart issues.

We last covered the Xenios i-cor® system last November(2015) when the company announced it had received CE mark approval for the device.

The i-cor system is a small extracorporeal pump that is synchronized to the heart beat (the ECG) so that augmentation of cardiac output with well-oxygenated blood occurs during diastole. The i-cor system, which provides Synchronized Cardiac Assist, combines the best elements of cardiac assist and augmented cardiac function associated with IABP and percutaneous ventricular assist devices but does not increase left ventricular afterload or ventricular work.

Synchronized Cardiac Assist, as offered by the i-cor system, superimposes a physiological pulse wave onto the patient’s weakened pulse. It is designed to be a less invasive treatment than the current standard, while using a more physiological treatment essential to endothelial function, thereby ensuring adequate tissue perfusion in the organs. Maintaining organ function serves to prevent multi-organ failure and to improve clinical outcomes. The oxygenating power of the i-cor Synchronized Cardiac System allows for a reduction of invasiveness compared to standard care by reducing blood flow and thus reducing cannula size. As a result, i-cor is designed to offer physiological circulatory support, protection, and safety during interventions in the cardiac cath lab, as well as for the management of cardiogenic shock in the ICU and the cardiac cath lab.

The SynCor trial is a prospective, non-randomized, multi-center, open-label observational study of the safety and performance of the i-cor System in 45 consecutively enrolled patients with cardiogenic shock or in high-risk percutaneous intervention procedures in the cardiac catheterization lab.

Company comments

“The i-cor Synchronized Cardiac Assist System represents an entirely new era for percutaneous circulatory support in heart failure,” said Georg Matheis, MD, Managing Director of XENiOS.

“The i-cor® Synchronized Cardiac Assist device reduces the mechanical and energy required by the heart to generate adequate blood pressure and blood flow to perfuse the tissues of each organ,” added Dr. Matheis.

“The purpose of the SynCor trial is to study the safety and performance of the i-cor® Synchronized Cardiac Assist device in order to optimize the performance of our device in the setting of cardiogenic shock following or associated with cardiac ischemic events, as well as in the setting of high-risk percutaneous intervention procedures in the cardiac catheterization lab. We look forward to reporting the results of this study.”